510(k) K043232 ยท NKB Thoracolumbosacral Pedicle Screw System
UCR SPINAL SYSTEM
| Applicant | Seaspine, Vista CA, US |
| Decision | Substantially Equivalent, Dec 21, 2004 |
| Received | Nov 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2014 | SeaSpine Inc Integra UCR 3mm Hex, Large Axial Driver.
The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.